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Process Development

Process Development

We follow our clients through the drug development value chain, taking the results from the lab to the pilot plant, developing new robust, reliable and cost-effective processes. We have an expert staff dedicated to the design and development of an economical, reproducible and scalable synthetic route that ultimately will obtain a product that complies with the market’s strict purity requirements.

This type of project requires a detailed state-of-the-art examination (patents and papers), the development of a non-infringement route, study of the critical points and tune up of reaction variables of each synthetic step, the development of accurate analytical methods to monitor the process and the quality of the final product. The technology is later transferred to the pilot plant.

Our joint venture with Applus+, GalChimiApplus, allow us to deliver pilot plant batches for preclinical work and also GMP batches of product for Phase I studies. Check the GalChimiApplus website for more info about our expertise and capabilities.

With every project, you will get:

Route scouting and assessment

Industrialization of a given RoS

Identification of critical points and stress out

Optimization of key steps through DoE

Development of analytical package for process control and regulatory monitoring